| Product No | EMEA/H/C/005330 |
|---|---|
| Brand Name | Celdoxome pegylated liposomal |
| Nonproprietary Name | doxorubicin hydrochloride |
| API | doxorubicin hydrochloride |
| ATC Code | L01DB01 |
| Indications | Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline). |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | YES Pharmaceutical Development Services GmbH |
| Status | Authorised(授权) |
| Authorization Date | 2022-09-15 |
| Version | 0 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information